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HEALTH PROFESSIONAL · SOURCE READING

Immune checkpoint inhibitor therapy

Source: Soft Tissue Sarcoma Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: February 21, 2025 · Captured 2026-09-09.

Selected source text with whitespace normalised. This Triangle page is not an NCI PDQ summary.

Context: Treatment of Recurrent Soft Tissue Sarcoma / Treatment Options for Recurrent Soft Tissue Sarcoma

Two trials have explored the immune checkpoint inhibitors pembrolizumab, nivolumab, and ipilimumab. Although some activity has been shown in selected soft tissue sarcoma subtypes, the factors that may predict activity to treatment with immune checkpoint inhibitors remain unknown, and their use cannot be routinely recommended.

Evidence (immune checkpoint inhibitors):

The phase II Sarcoma Alliance for Research through Collaboration trial (SARC028 [NCT02301039]) studied treatment with pembrolizumab alone in patients with four soft tissue sarcoma subtypes: undifferentiated pleomorphic sarcoma, synovial sarcoma, leiomyosarcoma, and poorly differentiated or dedifferentiated liposarcoma.[22] Eighty patients were evaluable for response, with half of the patients in the soft tissue sarcoma group and half in the bone sarcoma cohort. Responses were noted in the following subtypes:

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The phase II Sarcoma Alliance for Research through Collaboration trial (SARC028 [NCT02301039]) studied treatment with pembrolizumab alone in patients with four soft tissue sarcoma subtypes: undifferentiated pleomorphic sarcoma, synovial sarcoma, leiomyosarcoma, and poorly differentiated or dedifferentiated liposarcoma.[22] Eighty patients were evaluable for response, with half of the patients in the soft tissue sarcoma group and half in the bone sarcoma cohort. Responses were noted in the following subtypes:

Four of 10 patients with undifferentiated pleomorphic sarcoma.

The phase II Sarcoma Alliance for Research through Collaboration trial (SARC028 [NCT02301039]) studied treatment with pembrolizumab alone in patients with four soft tissue sarcoma subtypes: undifferentiated pleomorphic sarcoma, synovial sarcoma, leiomyosarcoma, and poorly differentiated or dedifferentiated liposarcoma.[22] Eighty patients were evaluable for response, with half of the patients in the soft tissue sarcoma group and half in the bone sarcoma cohort. Responses were noted in the following subtypes:

Two of 10 patients with poorly differentiated or dedifferentiated liposarcoma.

The phase II Sarcoma Alliance for Research through Collaboration trial (SARC028 [NCT02301039]) studied treatment with pembrolizumab alone in patients with four soft tissue sarcoma subtypes: undifferentiated pleomorphic sarcoma, synovial sarcoma, leiomyosarcoma, and poorly differentiated or dedifferentiated liposarcoma.[22] Eighty patients were evaluable for response, with half of the patients in the soft tissue sarcoma group and half in the bone sarcoma cohort. Responses were noted in the following subtypes:

One of 10 patients with synovial sarcoma.

The phase II Sarcoma Alliance for Research through Collaboration trial (SARC028 [NCT02301039]) studied treatment with pembrolizumab alone in patients with four soft tissue sarcoma subtypes: undifferentiated pleomorphic sarcoma, synovial sarcoma, leiomyosarcoma, and poorly differentiated or dedifferentiated liposarcoma.[22] Eighty patients were evaluable for response, with half of the patients in the soft tissue sarcoma group and half in the bone sarcoma cohort. Responses were noted in the following subtypes:

Zero of 10 patients with leiomyosarcoma.

The phase II Sarcoma Alliance for Research through Collaboration trial (SARC028 [NCT02301039]) studied treatment with pembrolizumab alone in patients with four soft tissue sarcoma subtypes: undifferentiated pleomorphic sarcoma, synovial sarcoma, leiomyosarcoma, and poorly differentiated or dedifferentiated liposarcoma.[22] Eighty patients were evaluable for response, with half of the patients in the soft tissue sarcoma group and half in the bone sarcoma cohort. Responses were noted in the following subtypes:

The overall response rate was 18%.

The phase II Alliance A091401 study (NCT02500797) randomly assigned patients to receive nivolumab (n = 43) versus nivolumab and ipilimumab (n = 42) for the treatment of different soft tissue sarcomas.[23]

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The phase II Alliance A091401 study (NCT02500797) randomly assigned patients to receive nivolumab (n = 43) versus nivolumab and ipilimumab (n = 42) for the treatment of different soft tissue sarcomas.[23]

Two patients in the nivolumab group had an objective response (5%; one patient with alveolar soft-part sarcoma and one patient with leiomyosarcoma). Six patients in the combination group had an objective response (16%; two patients with leiomyosarcoma, one patient with myxofibrosarcoma, two patients with undifferentiated pleomorphic sarcoma, and one patient with angiosarcoma).

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